Digital patient-centred learning in medical education: A national learning platform with virtual patients as part of the DigiPaL project

Background: Due to the coronavirus pandemic, the medical faculties in the Federal Republic of Germany converted their curricula to digital formats on a large scale and very quickly in spring 2020 as an emergency measure. At the same time, a start was made on the nationwide exchange of digital teaching/learning materials via the online platform “LOOOP share” in order to save local resources. Among other things, virtual patient cases (VP) were shared across faculties for case-based learning, through which students can acquire clinical decision-making skills. Objectives: Within the framework of the cooperation project “National Learning Platforms for Digital Patient-Related Learning in Medical Studies” (DigiPaL), the usability of VPs for students and teachers should be improved, and the spectrum of disease patterns that are covered by VPs should be systematically expanded. Results: With the participation of many locations, a total of 150 VPs were developed by 96 case authors from 16 faculties, in addition to the existing 403 VPs. The thematic selection was made on the basis of criteria oriented to the National Competence Based Catalogue of Learning Objectives for Undergraduate Medical Education (NKLM). After completion, these VPs were also made available to all faculties for free use via “LOOOP share” and the CASUS learning platform. Discussion: Even after the pandemic, these developed VPs should be available to the faculties and thus make a lasting contribution to improve medical training in Germany – especially in light of digital teaching formats being expressly advocated on the basis of the adapted current Medical Licensure Act (ÄApprO). A possible application is interdisciplinary learning of clinical decision-making with the help of blended learning formats within the framework of a longitudinal curriculum. The large number of involved colleagues and faculties shows that the nationally coordinated development of VPs across faculties was commonly seen as useful.


Introduction
In the course of the restrictions imposed by the coronavirus pandemic, the "Act on the Protection of the Population in the Event of an Epidemic Situation of National Importance" was passed, which was intended to ensure the training of doctors, among other things [http://www.bgbl.de/xaver/bgbl/start.xav?startbk= Bundesanzeiger_BGBl&jumpTo=bgbl120s0587.pdf]. Based on this, §2 of the "Deviations from the Medical Licensing Act" explicitly created the legal option to use digital teaching formats as a substitute for theoretical face-to-face teaching formats and as a supplement for practical teaching formats in human medicine degree programmes [https://www.gesetze-im-internet.de/epi_ appro2002abwv/index.html]. However, the use of this option posed great challenges for the medical faculties in the spring of 2020: 1. many digital learning materials ("resources") were needed at each faculty at short notice, 2. the use of these resources had to be aligned with the content of their own curriculum; and 3. in particular, the core competence "Clinical Decision-Making" should be acquirable digitally if possible.
All three of the above challenges were addressed by the team of authors in a two-step process. In a first step, the faculties were supported in the short term in the implementation of teaching during the pandemic. This step was the basis for step 2 presented in this project report.
Step 2 ensures the sustainability of the project -especially with regard to the requirements of the new Medical Licensure Act (ÄApprO), whose entry into force is currently planned for 2025. 1.1.
Step 1: Short-term nationwide provision of already existing online resources The aim of this first step was to make already existing online resources available for use by faculties nationwide as quickly as possible. This should be possible free of charge via standard browsers as well as mobile devices.
In addition, the faculties should be enabled to easily compare the resources offered with their own curricula in order to be able to identify suitable supplements to their own face-to-face courses. One focus was the integration of virtual patient cases (VP) with regard to learning clinical decision-making as an important medical competence.

Networking of existing online resources (addressing challenge (1))
In March 2020, the internationally used LOOOP online platform was adapted by the team of developers at Charité -Universitätsmedizin Berlin so that digital resources can be shared and used by all faculties nationwide (see [https://looop-share.charite.de]). For this purpose, the faculties can upload links to their online accessible digital resources on "LOOOP share" and control the access rights to these resources. The platform was adapted in close consultation with the Association of Medical Faculties in Germany (MFT). Since June 2020, access to "LOOOP share" has been possible via the authentication and authorisation infrastructure of the German Research Network (DFN-AAI, see [https://doku.tid.dfn.de/de:aai:about]) on a uniform nationwide basis within the framework of a "Single Sign On". This low-threshold control of access rights was made possible by a grant from the Federal Ministry of Health (BMG), which has been in place since 01 June 2020, as part of the cooperation project "National Learning Platforms for Digital Patient-Related Learning in Medical Studies" (DigiPaL).

Use of online resources for own curriculum (addressing challenge (2))
To enable content-based navigation through the online resources linked in "LOOOP share", each resource was individually mapped to the content of the National Competence Based Catalogue of Learning Objectives for Undergraduate Medical Education (NKLM, version 1.0) [1] published in 2015. This mapping was carried out accord-ing to a concept for curricular mapping that has been developed since 2004 under the leadership of the Charité -Universitätsmedizin Berlin within the framework of the international LOOOP research network [2]. The basis of this concept, which is currently being used to map approx. 140 degree programs in 22 countries (see [https://looop.charite.de]), includes preliminary work by Harden [3] and Willett [4]. Faculties that have already mapped their own curricula against the NKLM 1.0 as part of the LOOOP research network will automatically be shown the resources that match their courses (linked to the same NKLM content). Faculties that do not map using LOOOP can identify suitable resources in "LOOOP share" via the navigation within the thematically structured NKLM.  The NKLM 2.0 defines a selection of diseases relevant for the core curricula of the faculties. These are in turn considered on the basis of individual clinical aspects (socalled "descriptors"), such as diagnostics, therapy, emergency treatment and management. Not all descriptors were marked as "relevant" for each disease in the NKLM. This is mainly due to two reasons: Firstly, certain aspects simply do not exist for some diseases, e.g. not every disease requires an emergency treatment. Secondly, only those aspects were marked as "relevant" in the NKLM which should already be learned by medical students. Additionally, a decision was made for each descriptor classified as "relevant" as to whether a cognitive (for example, the preparation of a patient-related diagnostic or therapy plan) or practical action competence should be acquired. Furthermore, for each disease it was marked whether it was a rare disease. Cross-links from each individual disease to other chapters of the NKLM were then used to define which diagnostics, therapy, etc. should be learned in the context of this disease. The diseases listed in the NKLM thus play a central role both in defining the clinical content of medical studies and in selecting the aspects of clinical decision-making relevant to the degree programme.

Project goals
As part of the BMG-funded DigiPaL project, the VP pool available nationwide via LOOOP share in 2020 should be expanded in such a way that, after expansion, it covers the diseases with relevant clinical action competencies in NKLM 2.0. The decision as to which VPs are additionally required should be made on the basis of standardised criteria (see 2. 2) using an analysis of the VPs already available in "LOOOP share". In order to identify the corresponding diseases, standardised criteria should be developed with regard to practical action competencies. Subsequently, all medical faculties nationwide should be able to participate in this process.

Project description 2.1. Establishing the decision-making and organisational structures
After approval of the DigiPaL project application by the BMG, which in addition to the project described here also included the development of a digital virtual emergency department (DIVANA), an "editorial board" was set up. This board was to approve the NKLM-based criteria to be developed for the purpose of selecting the disease topics for the VPs and also decide on the subsequent case allocation to the faculties. The case allocation was carried out by the MFT, the coordination of the VP revision or new development was taken over by the Institute of Medical Education at LMU Munich.

Development of standardised criteria for VP revision/creation
Standardised criteria for the selection of the most important diseases (and their descriptors) to be covered by VPs were developed by the GSt. on the basis of the NKLM 2.0. If one or more of the criteria shown in table 2 were met, a disease was included in the selection. The basic requirement was that it was not marked as a rare disease. In the criteria, emphasis was generally placed on marking an action compe-tence in order to take account of the VP's goal of acquiring competence in the area of "clinical decision-making". The combination of the descriptors "diagnostics" and "therapy" in criterion 1 was due to the fact that a clinical process can be represented very well, if action competence is required with regard to both descriptors. The same applies to the combination of the descriptors "diagnostics" and "management" in criterion 3. The descriptor "emergency therapy" includes both emergency diagnostics (or first of all the recognition of an emergency situation) and the initiation of first therapeutic steps -which is why this descriptor was considered in criterion 2. Here, however, the other descriptors were not relevant in combination, as there are many diseases for which it is only important for students to recognise the acute situation and initiate measures -but not to be able to carry out the general diagnostics and therapy of these sometimes complex diseases by themselves.

Analysis of required VPs and comparison with the already published VP pool
Using the criteria presented in 2.2, those diseases and descriptors of the NKLM 2.0 were filtered out that should be covered by VPs. With the help of the successor relationships to NKLM 1.0 defined in NKLM 2.0, the diseases of both catalogue versions were then compared with each other and the respective coverage by VPs already published in "LOOOP share" was analysed. The "gaps" identified in this coverage analysis could refer both to diseases not yet covered by VPs and to descriptors of already existing diseases not yet covered in published VPs. Based on these analyses, an existing pool of previously unpublished or no longer used older VPs (with extensive need for revision) was first searched for 75 suitable cases to cover the necessary topics. Subsequently, 75 new VPs were defined to be created in order to close the then remaining "gaps". In addition, a standardised procedure was adopted by the Editorial Board to determine how to proceed before applying the above criteria if -as is to be expected -not exactly 75 VPs needing revision and 75 new VPs are identified.
1. If too few VPs are identified from the analyses, "multifaceted diseases" should be added, even if they are already addressed in an existing CASUS case. These VPs should then cover an alternative disease focus. 2. If too many VPs were identified, the Editorial Board could exclude VPs that a) were less suitable for implementation as VPs from a content perspective or b) were already covered by enough similar VPs.

Tendering of the VPs and assignment to faculties
The 11 case packages (corresponding to the organ system chapters of the NKLM 2.0) were then tendered nationwide and distributed by the Editorial Board to preferably two applying faculties. These faculties were each to work on half of the advertised VPs and be available to each other as review partners.
The faculties received an allowance of 1,200 € for each newly created VP and 600 € for each VP needing revision. The reciprocal case review was included in this amount.

Creation of the VPs
The case authors received comprehensive training from the LMU, which included both the didactic design of VPs and the use of the CASUS authoring system. The 96 authors were individually accompanied throughout the entire process of case development, and all VPs received a formative didactic review with detailed revision suggestions after their first completion.

Provision of the VPs nationwide
After finalising the respective VPs, the authors were asked to provide short summaries for "LOOOP share". In addition, a mapping of the new/revised VPs against the NKLM 1.0, supported by the GSt, took place so that these VPs can also be easily integrated into the curriculum by the faculties on the basis of the summaries and the previous mapping.

Selection of the VPs needing revision
From the pool of VPs needing revision, 50 suitable cases were identified with the help of the criteria described under 2. The number of suitable VPs per disease to be covered was between 1 and 4 (see table 3) and a maximum of 2 VPs per disease were selected (finally 44 VPs needing revision were identified). Subsequently, further VPs needing revision were defined according to 2.3.1. and thus, the target of 75 VPs needing revision was reached.

Definition of the new VPs to be created
Within the framework of the procedure described under 2., a total of 81 diseases were identified that were neither covered by VPs already published nor by VPs needing revision. As described in 2.3.2, these diseases were then reduced to 75. Table 4 presents the six diseases (incl. the respective justification) for which no VPs were created.

Distribution of the VP revision and redrafting among the faculties
A total of 16 faculties applied in the tender process and were assigned to the 11 organ-related thematic packages     (see table 5). Table 6 provides an overview of the thematic allocation of the faculties.

Created VPs
All 150 VPs needing revision and new VPs were created between 01.11.2020 and 12.12.2021, peer reviewed and linked in "LOOOP share".

Discussion
The pool of VPs available free of charge nationwide was expanded within the framework of the DigiPaL project so that the most important aspects of the diseases listed in the NKLM are now covered by VPs. These VPs are accessible via the DFN-AAI with the help of the "LOOOP share"platform, which is also available free of charge, and can now be used for decentralised and supplementary teaching by the faculties. The format of the VP is particularly suitable for training of clinical decision-making (regarding diagnosis and therapy decisions). Thematically self-contained case collections represent a particular added value. The case collection on occupational and environmental medicine, which has been used at many faculties since 2007, is a successful example of this cross-faculty use of VPs [9]. However, VPs can generally only be used to illustrate cognitive action competence (i.e., for example, the independent creation of diagnostic and/or therapy plans) [10]. Therefore, supplementary teaching of procedural and manual skills (handling; practice through simulations) is necessary to enable successful implementation of what has been learned [10], [11].
Mapping the VPs to the NKLM made sense considering the NKLM is expected to become the binding basis for the nationwide core curricula after a further revision in 2025. The conception of the criteria was based on the assumption that initially only those diseases should be considered that students regularly encounter. The VP situation was intended as a "complaint-related consultation" and not in the sense of a preventive medical presentation. Furthermore, special importance was attached to a required "competence to act", since a certain independent action is expected of the students at the end of their studies. The criteria were developed and applied on the basis of the interim status of the NKLM at the end of 2020. It would be possible to compare whether the VPs to be included would have changed after finalisation of the NKLM 2.0 by April 2021. In view of the further development of the NKLM planned until 2025, however, it seems reasonable to carry out a review of the VPs selected by the developed criteria on the basis of a later version of the NKLM (e.g. version 2.1 planned for 2024) in order to adjust the pool of VPs according to the core curricular content. In addition, the development of VPs on the basis of the other NKLM diseases (which do not fit the criteria mentioned) is of course also possible in order to give students the opportunity to deal with these topics. One limitation of the DigiPaL project could be the focus of the VsP on diseases (instead of, for example, on consultation occasions in the sense of "leading symptoms"). This approach was due to the time pressure in the course of the pandemic, in order to enable rapid usability of the VPs. A focus on consultation causes would have meant that the lecturers would have had to look through all the published VPs with a suitable symptom to see whether they were actually related to the diagnosis they were to teach. In the context of the "re-mapping" of the VPs against the NKLM version 2.1 already considered above, however, an additional marking of the consultation occasions addressed in a VP would make sense.

Conclusion
The nationwide participation of 17 faculties reflects the great interest in the format of the VP as a component of a canon of methods for teaching clinical decision-making skills, which was certainly increased in the course of the special demands during the coronavirus pandemic. Considering the low expense allowance for the participating faculties, a certain intrinsic motivation of the participants can be assumed. Additionally, a certain amount of faculty and specialization visibility may also be a motivating factor. In our view, this shows that the expected resourcesaving synergy effects of cross-faculty planning and use of VPs have been accepted by many faculties. The rising usage of VPs also implies that the anticipated importance of VPs (especially during the decentralised teaching situation) was correctly assessed. Since all relevant aspects of the diseases defined in the project are now covered by VPs, the faculties already have a VP pool that can be used across the board as a methodological supplement to the established patient-related teaching formats (e.g. in the context of blended learning). This can also be used specifically for learning clinical decision-making after returning to face-to-face teaching, and can be easily adapted to each new version of the NKLM with the help of the developed criteria. As part of the DigiPaL project, the foundation was thus laid for a significant expansion of digital teaching within the framework of the new ÄApprO on the basis of the NKLM.